Інформація, отримана з іноземних систем повідомлення про продукцію, що становить серйозний ризик, за період 01.10.2019 – 31.12.2019

Великобританія

https://www.gov.uk/drug-device-alerts?keywords=&alert_type[]=devices&issued_date[from]=&issued_date[to]=

Arrow EZ-IO intraosseous vascular access needle sets – risk of needle stick injury

Manufactured by Teleflex Medical (Arrow) – do not use needles if the safety cap is not in place as the risk of needle stick injury is increased and sterility of the needle may be compromised if packaging is punctured.

Alert type: Medical device alert

Medical specialism: Anaesthetics

Issued: 19 December 2019

ApexPro telemetry server – risk of loss of alarms for ECG and pulse oximetry monitoring (MDA/2019/045)

Manufactured by GE – central monitoring station or bedside monitor may not provide visual or audible alarms for ECG arrythmias, lead failures or SpO2 monitoring when used with affected telemetry system.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 15 others

Issued: 18 December 2019

BritePro Solo and BriteBlade Pro single-use fibre optic laryngoscope blades and handles – risk of choking (MDA/2019/044)

Manufactured by Flexicare Medical – loose bearings and retaining ring may enter patient’s airway causing choking hazard if the laryngoscope blade is disengaged from the handle above the patient.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 3 others

Issued: 12 December 2019

Recall of Medicina IV Luer Slip syringe (IVS03) batch number 19040303 (MDA/2019/043)

Manufactured by Medicina – syringes incorrectly packaged with a needle could mean they are not sterile and could cause a needlestick injury.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 20 others

Issued: 11 December 2019

Natus gold cup electrodes and snap electrode leads – risk of electric shock

Manufactured by Natus - GN Otometrics A/S: an exposed conductor may cause an electric shock to the user or patient.

Alert type: Medical device alert

Issued: 5 December 2019

Spectra Optia apheresis: anticoagulant bags used with ‘Correct Connect’ connectors – risk of unbroken ‘frangible’ connector during use (MDA/2019/041)

Manufactured by Terumo BCT – inadequately broken anticoagulant ‘frangible’ may lead to clotting and inadequate therapy during apheresis procedures.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 3 others

Issued: 4 December 2019

Alaris™ Gateway Workstation and Alaris™ Gateway Workstation web browser user interface (MDA/2019/040)

Manufactured by Becton Dickinson – if a software security vulnerability is exploited, an attacker with malicious intention could remotely install unauthorised firmware.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 14 others

Issued: 27 November 2019

Professional use defibrillator/monitor: Efficia DFM100 (Model number 866199) – risk of failure to switch on or unexpected restart (MDA/2019/039)

Manufactured by Philips – due to a software or hardware issue the device may fail to start or deliver defibrillation therapy.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 17 others

Issued: 31 October 2019

Syringe driver pumps: T34™ 3rd edition models only – stop using the pump until updated instructions for use and BodyCommTM V3.0 software are released (MDA/2019/038)

Manufactured by CME (a BD company) – the intended operation of these pumps cannot be verified due to errors in the instructions for use (IFUs) and the incompatibility with older versions of BodyComm software (88-102).

Alert type: Medical device alert

Medical specialism: Care home staff and 3 others

Issued: 29 October 2019

Prismaflex haemofiltration systems installed with software versions 8.10, 7.20 and lower – risk of unexpected machine shutdown during treatment (MDA/2019/037)

Manufactured by Baxter – Communication error alarms may result in unintentional delay and interruption of treatment due to system shutdown.

Alert type: Medical device alert

edical specialism: Anaesthetics and 4 others

Issued: 10 October 2019

Specific Hudson RCI Sheridan endotracheal tubes and connectors - 15 mm connector may detach from the tube before or during use (MDA/2019/036)

Manufactured by Teleflex Medical – disconnection can result in inadequate oxygenation and ventilation requiring medical intervention to avoid hypoxia, severe neurological injury or death.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 2 others

Issued: 10 October 2019

Rocket and NuSurgix fetal blood sampling (FBS) amnioscopes and FBS kits – stop using ethyl chloride spray during the fetal blood sampling procedure with these devices (MDA/2019/035)

Manufactured by Rocket Medical and NuSurgix – potential incompatibility between ethyl chloride spray and the device.

Alert type: Medical device alert

Medical specialism: Obstetrics and gynaecology

Issued: 9 October 2019

Intraoperative probe cover with long Surgi-tip – risk of infection due to manufacturing failure (specific lot numbers affected) (MDA/2019/034)

Manufactured by Ecolab/Microtek Medical Malta Ltd – bacterial contamination may cause an infection in patients.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 12 others

Issued: 9 October 2019

Anaesthetic face masks – Specific Intersurgical Economy 22F taper connection may be oversized and leak or disconnect from the breathing circuit (MDA/2019/033)

Manufactured by Intersurgical – leaks or disconnection can result in insufficient oxygenation requiring medical intervention to avoid severe injury.

Alert type: Medical device alert

Medical specialism: Anaesthetics and 2 others

Issued: 8 October 2019

Breathing circuit swivel elbow – recall due to risk of cracks forming before or during use (MDA/2019/032)

Manufactured by Intersurgical, used in devices made by other companies: cracks in swivel elbow connectors may lead to prescribed ventilation not being delivered.

0.12.2019	Datex-Ohmeda Inc.	Giraffe OmniBed Model: see FSN Giraffe OmniBed Carestation Model: see FSN Giraffe Incubator Carestation Model: see FSN Giraffe Incubator Model: see FSN	MD: Conventional infant incubator MD: Conventional infant incubator MD: Conventional infant incubator MD: Conventional infant incubator	DE-1 FR-1 IT-1 EN-1	Vk_20191223_30
30.12.2019	Medartis AG	2.5 Trilock Screw 14mm, HD7 Model: A-5750.14/1S Lot: 17169656, 18190766, 19194557, 19200335	MD: Orthopaedic bone screw, non-bioabsorbable, sterile	DE-1 FR-1 IT-1 EN-1	Vk_20191220_07
20.12.2019 (Updated 30.12.2019)	Medtronic (Schweiz) AG	POLYSORB suture Model: CL915; CL914; CL923; CL925; UL203; SL5690; CL461; CL537; CL811; CL815; CL885; CL911; CL953; GL123; GL124; GL228; GL323; GLS322; L1742K; L2752K; SL1625G; SL5679; SL654; UL877; UL878 Lot: See appendix of FSN Biosyn Suture Model: UM201 Lot: See appendix of FSN	MD: Polyester suture, bioabsorbable, multifilament MD: Polyester suture, bioabsorbable, monofilament	DE-1 FR-1 IT-1 EN-1	Vk_20191219_01
30.12.2019	Mavidon Medical Products	LemonPrep, PediaPrep, Wave Prep, Cardio Prep Model: Tubes and Single Use Cups Lot: all	MD: Electrode conductive medium	EN-1	Vk_20191203_06
27.12.2019	RaySearch Laboratories AB	RayStation Model: see FSN Lot: see FSN	MD: Radiation therapy software	EN-1	Vk_20191227_10
27.12.2019	Integra LifeSciences	IDRT - Single Layer and IDRT TS Model: 62021; 82021; 84051; 88101 Lot: See FSN	MD: Skin regeneration template, human-/animal-derived	DE-1 FR-1	Vk_20191227_05
27.12.2019	GE Healthcare	Centricity Universal Viewer SW-Version: 6.0	MD: Medical image management system	DE-1 FR-1 IT-1 EN-1	Vk_20191223_46
27.12.2019	W.L. Gore & Associates	GORE EXCLUDER AAA Endoprosthesis Model: See attachment GORE EXCLUDER Iliac Branch Endoprosthesis Model: See attachment	MD: Abdominal aorta endovascular stent-graft MD: Iliac Branch endovascular stent-graft	EN-1	Vk_20191219_26
17.12.2019 (Updated 27.12.2019)	Synthes GmbH	Sterile Screw implants packed in Sterile Tubes Model: size M Lot: part numbers ending in suffix TS	MD: Orthopaedic bone screw, non-bioabsorbable, sterile	DE-1 FR-1 IT-1	Vk_20191213_06
23.12.2019	Karl Storz Endoskope SE und Co. KG	Insufflation Tubing Set, with gas filter Model: 030247-10, 031123-10, 031200-03, 031200-10, 031222-10, 031322-10, 031432-10, 031532-10, 031622-10 Lot: see FSN	MD: Endoscopic insufflation tubing set, single-use	DE-1 FR-1 IT-1 EN-1	Vk_20191223_41
20.12.2019	Fast-Track Diagnostics S.a.r.l.	FTD Respiratory pathogens 21 Model: FTD-2-32, FTD-2-64 Lot: all lots	IVD: Multiple respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	DE-1 FR-1 IT-1 EN-1	Vk_20191219_21
20.12.2019	Leonhard Lang GmbH	GS defibrillation electrodes Model: corPatch easy 04324.3 Lot: 190711-3993	MD: Electrodes, Cardiac, External Defibrillator	DE-1 EN-1	Vk_20191219_20
20.12.2019	Fresenius Kabi (Schweiz) AG	PatientOnLine Model: F989951, F989901 S/N: All Software with Version 6.2 SW-Version: Version 6.2	MD: Nephrology information system application software	EN-1	Vk_20191218_14
20.12.2019	Medtronic Sofamor Danek USA, Inc.	AsterX Expandable Corpectomy System Model: see FSN Lot: All	MD: Vertebral body prosthesis, non-sterile	EN-1	Vk_20191218_09
20.12.2019	Carestream Health Inc	Carestream DRX-Evolution and DRX-Evolution Plus	MD: Stationary basic diagnostic x-ray system, digital	DE-1 FR-1	Vk_20191217_14
20.12.2019	VitreQ B.V.	VitreQ Model: Multiple Lot: all	MD: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use	DE-1 FR-1 IT-1	Vk_20191217_12
20.12.2019	Abbott Diagnostics Technologies AS	NycoCard D-Dimer Model: 1116081, 1116082 Lot: see FSN	IVD: D-dimer IVD, reagent	DE-1 FR-1 IT-1 EN-1	Vk_20191211_03
20.12.2019	RAL DIAGNOSTICS	Giemsa Solution for SP Automated System Model: 75030SX1000 Lot: I88021 exp.20.05.2021; I97523 exp. 03.06.2021; I63818 exp. 20.05.2021	IVD: Biological stain IVD	EN-1	Vk_20191211_01
18.12.2019 (Updated 20.12.2019)	Morcher GmbH	EYEJET CTR Model: Typ 13 right, Typ 13A right, Typ 13B right Lot: BKADBC S/N: 2540604-2541803	MD: Capsular tension ring	DE-1 EN-1	Vk_20191206_21
20.12.2019	CAIR LGL	Naso-duodenal feeding tube Model: NCE2..G	MD: Nasoenteral tube	DE-1 FR-1 IT-1	Vk_20191204_14
20.12.2019	Laboratoires ANIOS (ECOLAB)	ANIOSYME DD1 Lot: B28123S	MD: Medical device disinfectant	DE-1 FR-1 IT-1 EN-1	Vk_20191120_11
19.12.2019	Datex-Ohmeda, Inc (GE Healthcare)	Carestation 620 A1 / 650 A1 / 650c A1 S/N: see fsn	MD: Anaesthesia workstation, general-purpose	DE-1 FR-1 IT-1 EN-1	Vk_20191218_05
17.12.2019 (Updated 19.12.2019)	Intuitive Surgical, Inc	Endoscope and Camera Head Sterilization Tray Model: 400498-02, 400499-03; 8mm Lot: all	MD: Instrument tray	DE-1 FR-1 IT-1 EN-1	Vk_20191213_10
19.12.2019	Eppendorf AG	Centrifuge 5910 R Model: see FSN Lot: see FSN	IVD: Aliquoters - Sorters - Centrifuges - Decappers - Recappers (SP)	DE-1 FR-1 EN-1	Vk_20191213_01
19.12.2019	Homoth Medizinelektronik GmbH & Co.KG	Air Calorisator Model: 80-1110 Lot: see FSN SW-Version: 3.0x	MD: Caloric irrigation unit	DE-1 EN-1	Vk_20191212_08
19.12.2019	Ulrich AG	Schulterhebel Darrach Model: U40-576-00 Lot: AE106263	MD: Bone lever/elevator	DE-1	Vk_20191209_08
30.04.2019 (Updated 19.12.2019)	Maquet SAS	VOLISTA Model: STANDOP & TRIOP	MD: Operating light	DE-1 DE-2 FR-1 FR-2 EN-1 EN-2	Vk_20190424_08
18.12.2019	B. Braun Melsungen AG	Original Perfusor Line Model: 8726019 Lot: 61676305	MD: Intravenous administration tubing extension set	DE-1	Vk_20191216_15
18.12.2019	Fast-Track Diagnostics S.a.r.l.	FTD CE-IVD Kits Model: see FSN Lot: see FSN	IVD: IVD kits for the detection of various pathogens	DE-1 FR-1 IT-1 EN-1	Vk_20191216_14
28.10.2019 (Updated 18.12.2019)	Stryker Endoscopy	PKG,STRYKEFLOW ELECROCAUTERY P Model: 0250070450, 0250070460 Lot: see FSN	MD: Universal hand-controlled electrosurgical diathermy system conducting unit, reusable	DE-1 FR-1 IT-1 EN-2	Vk_20191021_02
17.12.2019	Maquet SAS	Sterilizable handle "Hanaulux" Model: ARD568303903; ARD568335999; ARD568350904 Lot: 50025; 40091; 40033; 50014 S/N: All products manufactured between October 2007 and November 2017	MD: Operating light	EN-1	Vk_20191212_13
17.12.2019	Randox Laboratories Ltd	Liquid Chemistry Control Premium Plus Model: LAE4217 Lot: 1021UE	IVD: Multiple clinical chemistry analyte IVD, control	DE-1 FR-1 IT-1 EN-1	Vk_20191212_01
11.12.2019 (Updated 16.12.2019)	ResMed Ltd.	Stellar Model: 100, 150; 24141, 24142, 24143, 24144, 24145, 24151, 24152, 24153, 24154, 24155 S/N: 20160123307 to 22171057208	MD: Portable electric ventilator	DE-1 FR-1 IT-1 EN-1	Vk_20191205_17
16.12.2019	Gebrüder Martin GmbH & Co. KG	Skalpellklinge Model: see FSN Lot: see FSN	MD: Scalpel blade, single-use	DE-1 FR-1 IT-1	Vk_20191205_09
16.12.2019	Stryker Trauma Kiel	Delta Strike Plate IMN Instruments Model: 23510050 Lot: all lots	MD: Bone nail driver	DE-1 FR-1 IT-1 EN-1	Vk_20191205_03
10.12.2019 (Updated 13.12.2019)	ViewRay Inc.	Stereotactic radiotherapy/MRI System Model: MRIdian Linac System; 10000, 20000 S/N: ALL SW-Version: 4.x	MD: Stereotactic teletherapy radionuclide system, MRI-imaging	DE-1 EN-1	Vk_20191204_08
05.12.2019 (Updated 12.12.2019)	Elekta Limited	Elekta Unity	MD: Linear accelerator system	FR-1 EN-1	Vk_20191129_21
27.11.2019 (Updated 12.12.2019)	Edwards Lifesciences LLC	HemoSphere Oximetry Cable Model: HEMOXSC100 Lot: N/A SW-Version: N/A	MD: Single-patient physiologic monitoring system	DE-1 FR-1 IT-1 EN-1	Vk_20191122_02
21.11.2019 (Updated 12.12.2019)	Philips Goldway (Shenzhen) Industrial Inc.	Efficia DFM 100 Model: 866199 S/N: See UAL86100207	MD: Rechargeable professional automated external defibrillator	DE-1 customer DE-1 distributor DE-2 customer DE-2 distributor FR-1 customer FR-2 customer IT-1 customer IT-2 customer EN-1 customer EN-1 distributor EN-2 customer EN-2 distributor	Vk_20191118_07
11.12.2019	GE Medical Systems	SIGNA PET/MR Discovery MR750w 3.0T, Discovery MR750 3.0T, Optima MR450w 1.5T, Discovery MR450 1.5T, SIGNA Architect, SIGNA Artist	MD: PET/MRI system MD: Full-body MRI system, superconducting magnet	DE-1 FR-1 IT-1 EN-1	Vk_20191209_02